Application 079213
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 75MG | No | No |
| 002 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 150MG | No | No |
| 003 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68382-299 | Irbesartan | Irbesartan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-299 | Irbesartan | Irbesartan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-299 | Irbesartan | Irbesartan | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-300 | Irbesartan | Irbesartan | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-300 | Irbesartan | Irbesartan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-300 | Irbesartan | Irbesartan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-301 | Irbesartan | Irbesartan | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-301 | Irbesartan | Irbesartan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-301 | Irbesartan | Irbesartan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1159 | Irbesartan | Irbesartan | Cadila Healthcare Limited | ANDA | Current |
| 70771-1159 | Irbesartan | Irbesartan | Cadila Healthcare Limited | ANDA | Current |
| 70771-1159 | Irbesartan | Irbesartan | Cadila Healthcare Limited | ANDA | Current |
| 70771-1159 | Irbesartan | Irbesartan | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1160 | Irbesartan | Irbesartan | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1160 | Irbesartan | Irbesartan | Cadila Healthcare Limited | ANDA | Current |
| 70771-1160 | Irbesartan | Irbesartan | Cadila Healthcare Limited | ANDA | Current |
| 70771-1160 | Irbesartan | Irbesartan | Cadila Healthcare Limited | ANDA | Current |
| 70771-1161 | Irbesartan | Irbesartan | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1161 | Irbesartan | Irbesartan | Cadila Healthcare Limited | ANDA | Current |
| 70771-1161 | Irbesartan | Irbesartan | Cadila Healthcare Limited | ANDA | Current |
| 70771-1161 | Irbesartan | Irbesartan | Cadila Healthcare Limited | ANDA | Current |